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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Dental Dam, Natural Latex, Unflavored, 5" x 5", Heavy Black
CROSSTEX INTERNATIONAL, INC.
19701
In Commercial Distribution

  • 50732224005596 ()
  • 10732224005598 ()
  • 00732224005591 ()


  • Rubber dam, Hevea-latex
DHP Dental Dam 5" x 5" Green Heavy 52/box
Dental Health Products Inc
810-10003
In Commercial Distribution

  • D773810100031 ()
810-10003

  • Rubber dam, Hevea-latex
DHP Dental Dam 5" x 5" Green Medium 52/box
Dental Health Products Inc
810-10002
In Commercial Distribution

  • D773810100021 ()
810-10002

  • Rubber dam, Hevea-latex
DHP Dental Dam 5" x 5" Green Thin 52/box
Dental Health Products Inc
810-10001
In Commercial Distribution

  • D773810100011 ()
810-10001

  • Rubber dam, Hevea-latex
SPINE RETRACTOR 5" DEEP 90 DEG ANGLE 5" MAX SPREAD
ORTHO-MED, INC.
OM 52-0775
In Commercial Distribution

  • B8035207750 ()


  • Self-retaining surgical retractor, reusable
McCulloh Type Suction Tube, WL 5 3/4", 5 Fr
BOSS INSTRUMENTS, LTD., INC.
74-5505L
In Commercial Distribution

  • 00888515197169 ()
74-5505L

  • Surgical/emergency suction cannula, non-illuminating, reusable
5 5/8" Cushing Dura Hook, Sharp, Hook Depth 3.5mm
Surgical Direct, Inc.
SD928520510
In Commercial Distribution

  • B382SD9285205100 ()
SD928520510

  • Laparoscopic access cannula, reusable
CBC-Tech: 10 x 3.5mL Dual Pack (5 Low, 5 High)
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
CT002
In Commercial Distribution

  • 00815762020872 ()

  • Total Volume: 35 Milliliter
CT002

  • Full blood count IVD, control
CBC-7: 10 x 2mL Dual Pack (5 Low, 5 High)
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
72002
In Commercial Distribution

  • 00815762020353 ()

  • Total Volume: 20 Milliliter
72002

  • Full blood count IVD, control
CBC-3K: 10 x 3mL Dual Pack (5 Low, 5 High)
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
3K302
In Commercial Distribution

  • 00815762020261 ()

  • Total Volume: 30 Milliliter
3K302

  • Full blood count IVD, control
CBC-3D: 10 x 2mL Dual Pack (5 Low, 5 High)
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
3D502
In Commercial Distribution

  • 00815762020100 ()

  • Total Volume: 20 Milliliter
3D502

  • Full blood count IVD, control
Integra® BRS RETRACTOR BLADE 5/32" TO 5/8"
INTEGRA LIFESCIENCES CORPORATION
417A1006
In Commercial Distribution

417A1006

  • Neurosurgical retraction system, brain
5 5/16 inch Meltzer Adnoid Punch, Curved, 8mm Bite
Surgical Direct, Inc.
SD921187121
In Commercial Distribution

  • B382SD9211871210 ()
SD921187121

  • Orthopaedic joint/limb rongeur
5 5/8" Double Prong Micro Hook, Sharp, 2mm Tip
Surgical Direct, Inc.
SD922641102
In Commercial Distribution

  • B382SD9226411020 ()
SD922641102

  • Bone lever/elevator, reusable
5 5/8 inch Love Nerve, Vessel Hook 2mm, Small
Surgical Direct, Inc.
SD90703110
In Commercial Distribution

  • B382SD907031100 ()
SD90703110

  • Self-retaining surgical retractor, reusable
Integra® BRS Retractor Blade 5/32" to 5/8"
INTEGRA LIFESCIENCES CORPORATION
417A1006
In Commercial Distribution

  • M268417A10061 ()
  • 10381780253884 ()

  • Tapered 5/32" to 5/8"
417A1006

  • Neurosurgical retraction system, brain
5 1/2 inch Hoke Osteotome, 5/8 inch , Straight
Surgical Direct, Inc.
SD91440415
In Commercial Distribution

  • B382SD914404150 ()
SD91440415

  • Orthopaedic osteotome
CERVICAL INTERFIXATED TRIAL, 5 x 18 x 16 mm, 5°
ALPHATEC SPINE, INC.
135-10-05181605
In Commercial Distribution

  • 00190376272634 ()

  • Angle: 5 degree
  • Depth: 16 Millimeter
  • Height: 5 Millimeter
  • Width: 18 Millimeter


  • Spinal implant trial
CERVICAL INTERFIXATED TRIAL, 5 x 20 x 16 mm, 5°
ALPHATEC SPINE, INC.
135-10-05201605
In Commercial Distribution

  • 00190376272665 ()

  • Width: 20 Millimeter
  • Angle: 5 degree
  • Depth: 16 Millimeter
  • Height: 5 Millimeter


  • Spinal implant trial
CERVICAL INTERFIXATED TRIAL, 5 x 16 x 14 mm, 5°
ALPHATEC SPINE, INC.
135-10-05161405
In Commercial Distribution

  • 00190376272603 ()

  • Width: 16 Millimeter
  • Angle: 5 degree
  • Depth: 14 Millimeter
  • Height: 5 Millimeter


  • Spinal implant trial
CERVICAL INTERFIXATED TRIAL, 5 x 14 x 12 mm, 5°
ALPHATEC SPINE, INC.
135-10-05141205
In Commercial Distribution

  • 00190376272566 ()

  • Width: 14 Millimeter
  • Height: 5 Millimeter
  • Depth: 12 Millimeter
  • Angle: 5 degree


  • Spinal implant trial
Operative Carbide Bur HP 5 5pk Round HP 5 5pk
US ENDODONTICS, LLC
HP55
In Commercial Distribution

  • 10818365025241 ()
  • 00818365025244 ()
HP55

  • Carbide dental bur, single-use
Operative Carbide Bur RA 5 10pk Round RA 5 10pk
US ENDODONTICS, LLC
RA510
In Commercial Distribution

  • 10818365025029 ()
  • 00818365025022 ()
RA510

  • Carbide dental bur, single-use
Operative Carbide Bur FG 5 10pk Round FG 5 10pk
US ENDODONTICS, LLC
FG510
In Commercial Distribution

  • 10818365024084 ()
  • 00818365024087 ()
FG510

  • Carbide dental bur, single-use
ST.SECUREVIEW PT 5 5/8' X 6 1/2' AFZ
CENTURION MEDICAL PRODUCTS CORPORATION
SCVP66XT-6
In Commercial Distribution

  • 00653160270211 ()
  • 10653160270218 ()
SCVP66XT-6

  • Wearable percutaneous catheter/tube holder
Monopolar Cable 5 mtr. 5 mm plug / 4 mm socket
Günter Bissinger Medizintechnik GmbH
80100115
In Commercial Distribution

  • 04250418700825 ()
80100115

  • Electrical-only medical device connection cable, reusable
5 Deg 14 mm Dual-Sided Trial, 5 & 6 mm H
Tyber Medical LLC
002-C140506
In Commercial Distribution

  • M695002C1405060 ()
002-C140506

  • Metal-polymer composite spinal interbody fusion cage
STERLING Handpiece 1:5 Increasing Fiber-Optic ERL 95 1:5
BENCO DENTAL SUPPLY CO.
5259-507
Not in Commercial Distribution

  • 00366975069344 ()


  • Fibreoptic dental light
STERLING Handpiece 1:5 Increasing Fiber-Optic ERL 95 1:5
BENCO DENTAL SUPPLY CO.
5259-507
In Commercial Distribution

  • 00366975013040 ()


  • Fibreoptic dental light
GC CROWNTEK™ Refill Size, 5 crowns of Premolar 5
Gc America Inc.
412130
Not in Commercial Distribution

  • D6584121301 ()
  • D6584121300 ()
412130

  • Preformed dental crown, temporary
ELMED BIPOLAR FORCEPS, IN MALIS STYLE, 5 T STR 5"
ELMED INCORPORATED
5970-05D
In Commercial Distribution

  • 00842180138667 ()
5970-05D

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Cooley Pediatric Clamp Fig. 5 curved, 125mm, 5'' shanks curved
RZ-Medizintechnik GmbH
290-573-005
In Commercial Distribution

  • 04049197210867 ()
290-573-005

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
BALFOUR NARROW BLADES, 1 5/8"X2 5/8" BLADES
HNM STAINLESS, LLC.
HNM-1-24-5026B
In Commercial Distribution

  • 00842962114926 ()
HNM-1-24-5026B

  • Surgical retractor/retraction system blade, reusable
DANDY SCALP FORCEPS, 5 5/8", 1X2 TEETH, CVD SIDEWAY
HNM STAINLESS, LLC.
HNM-1-16-1194
In Commercial Distribution

  • 00842962111475 ()
HNM-1-16-1194

  • Dressing/utility forceps, tweezers-like, reusable
mcculloch suction tube, 5 3/4" (14.5 cm), 5 fr.
NOVO SURGICAL, INC.
N6868-14
In Commercial Distribution

  • 00842331192043 ()


  • Bone curette, reusable
AERAS 5 DRY VACUUM ONLY 5 USER, 230VAC, 1 PHASE
Dentalez Alabama, Inc.
RV52
In Commercial Distribution

  • D060RV520 ()


  • Dental suction system pump
Ring-Handled Channel Brush 1.67mm (5 French) 6"Length - 5 Brushes
CYGNUS MEDICAL L.L.C.
90-005
In Commercial Distribution

  • 30843356100021 ()
  • 00843356100020 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
crawford retrieving hook, round handle, 5 5/8" (14.3 cm)
NOVO SURGICAL, INC.
OP7120-99
In Commercial Distribution

  • 00842331157691 ()
OP7120-99

  • Eye muscle hook, reusable
New's Suture Scissors 5 5/8" (142mm), angled on flat
RZ-Medizintechnik GmbH
120-225-165
In Commercial Distribution

  • 04049197508414 ()
120-225-165

  • General-purpose surgical scissors, reusable
Ti Mini plate 5 holes int sect 2x7.5mm p/5
Medicon eG. Chirurgiemechaniker-Genossenschaft
68.70.15
In Commercial Distribution

  • 04046826120115 ()
  • 04046826318048 ()
68.70.15

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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